Orthostatic hypotension is a major complication of hemodialysis and interferes with everyday activities in hemodialysis patients. Since information regarding the use of droxidopa in clinical trials relating to orthostatic hypotension of chronic hemodialysis patients is limited in Taiwan, this study is designed for evaluation the efficacy and safety profile of droxidopa on orthostatic hypotension treatment / prevention in hemodialysis patients.

A Double-blind, Randomized and Placebo-controlled Study to Evaluate the Efficacy and Safety of L-threo-3,4-dihydroxyphenylserine (Droxidopa) on Orthostatic Hypotension Treatment in Hemodialysis Patients

Patient with a decrease of 20 mmHg in SBP or 10 mmHg in DBP within 5 minutes of standing after the end of hemodialysis in at least 2 of 3 sessions during the screening period.

Subject with subjective complain of light headedness related to the orthostatic hypotension AND with a VAS score 4 in at least 2 of 3 sessions during the screening period.

Willing and able to comply with the study procedure and sign a written informed consent

Exclusion Criteria:

Female who is pregnant, lactating or planning to be pregnant within 3 months, or female of childbearing potential who is not using medically recognized method of contraception

Subject with closed angle glaucoma

Subject with severe hypertension

Subject with liver disorder

Subject with Hct great than 36%

Subject with confusion, hallucination, or delusion

Subject with severe disease which may limit survival during the study period, or confound the results of the study as judged by the investigator, such as hyperthyroidism, artery stenosis, severe lung disorders, severe asthma, chronic open angle glaucoma, uncontrolled diabetic gangrene

Subject who takes any anti-hypotensive drugs within 7 days prior to randomization, such as midodrine, etilefrine or amezinium

Subject who takes ephedrine, pseudoephedrine within 7 days prior to randomization

Subject who use of any investigational product within 4 weeks prior to randomization

Subject who requires blood transfusions within 3 months before screening, and are not suitable to participate the trial as judged by the investigator

Histories of hypersensitive to droxidopa

Histories of peripheral vascular disease, coronary artery disease and are not suitable to participate the trial as judged by the investigator

Histories of hemorrhage complication within 3 months before the screening visit, such as GI bleeding, intracranial bleeding or traumatic hemorrhage, and are not suitable to participate the trial as judged by the investigator

In investigator's opinion, subjects who are unlikely to adequately cooperate and follow the procedures

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01612078